Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-30 @ 5:22 PM
Study NCT ID:
NCT04676360
Status:
TERMINATED
Last Update Posted:
2025-09-25
First Post:
2020-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Belantamab Mafodotin In Plasmablastic Lymphoma & ALK+ Large B-Cell Lymphoma
Sponsor:
Jacob Soumerai, MD
Organization:
Study Overview
Official Title:
A Multicenter Phase 2 Study of Belantamab Mafodotin in Relapsed or Refractory Plasmablastic Lymphoma and ALK+ Large B-cell Lymphoma
Status:
TERMINATED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was closed given lack of efficacy and plans to publish this negative study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this research study is looking to see how safe and effective belantamab mafodotin is in relapsed or refractory plasmablastic lymphoma or ALK+ large B-cell lymphoma.
* This research study involves the study drug belantamab mafodotin.
* Belantamab mafodotin is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a drug. It works by using the antibody portion to enter into the lymphoma cells, and then releasing the drug portion to kill the lymphoma cells.
* This research study involves the study drug belantamab mafodotin.
* Belantamab mafodotin is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a drug. It works by using the antibody portion to enter into the lymphoma cells, and then releasing the drug portion to kill the lymphoma cells.
Detailed Description:
This is a multicenter phase 2 study of belantamab mafodotin on participants with plasmablastic lymphoma and ALK+ large B-cell lymphoma.The research study procedures include screening for eligibility, and study treatment, including evaluations and follow up visits.
* This research study involves the study drug belantamab mafodotin.
* Participants may receive the study treatment until progression or intolerance, and will be followed up to 2 years.
* It is expected that about 25 people will take part in this research study.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved belantamab mafodotin as a treatment for any disease. This study drug is investigational, and it is not known whether participants will benefit from taking belantamab mafodotin.
* This research study involves the study drug belantamab mafodotin.
* Participants may receive the study treatment until progression or intolerance, and will be followed up to 2 years.
* It is expected that about 25 people will take part in this research study.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved belantamab mafodotin as a treatment for any disease. This study drug is investigational, and it is not known whether participants will benefit from taking belantamab mafodotin.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: